Search results for " risk-based"
Article
Managing Residual Impurities During Downstream Processing
…niques for heavy-metal determination with inductively coupled plasma mass spectrometry (ICP-MS) in a risk-based approach for monitoring levels of potential elemental impurities.
Some specifics o…
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology
The agency launched an initiative in 2002 entitled Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach. One of the main goals of the 2002 initiative is encouraging new technology advances…
Article
GMP Challenges for Advanced Therapy Medicinal Products
It is also in line with the emphasis placed by the European Commission’s consultative document on the need for a risk-based approach with the application of GMP for ATMPs.
The document (1) is mainl…
Article
The Metrics of Quality Culture
…f a drug or drugs (referred to in this subsection as ‘drug establishments’) in accordance with a risk-based schedule established by the Secretary.” Section 706 of the same act allows FDA to request c…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
PDA TR 68, Risk-Based Approach for Prevention and Management of Drug Shortages, provides an excellent overview of the QRM process to prevent/manage supply shortages for biopharmaceuticals (and other d…
Article
Quality by design for biotechnology products—part 1
…nufacturing that entails building quality into the process and product in a systematic, science- and risk-based manner. The QbD concepts outlined in the International Conference on Harmonization (ICH…
Article
Digitalization: The Route to Biopharma 4.0
The strategy was demonstrated as being effective in managing continuous data and thereby facilitating risk-based decision making.
Digitalization in quality assurance/quality control
Digita…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Closed processing is essential because it provides a better response when using a risk-based approach, adds Nestola.
Single-use equipment is therefore one of the biggest equipment-related solution…
Article
Understanding and Controlling Raw Material Variation in Cell Culture Media
Manage variability through advanced analytical methods and risk-based assessment.
Click here to read more >>
Article
Good Manufacturing Practices: Challenges with Compliance
This [expedited timeline] drives the need for early and continuous engagement with the agency to ensure transparency and shared understanding of risk-based, scientifically sound approaches being lever…